Superparamagnetic iron oxide particles (SH U 555 A): evaluation of efficacy in three doses for hepatic MR imaging.
OBJECTIVE
To evaluate the efficacy of SH U 555 A in three doses for magnetic resonance (MR) imaging in the liver and to establish the best postinjection time point for liver MR imaging.


METHODS
Pre- and postcontrast image sets obtained in 169 patients after injection of SH U 555 A (randomly, 4, 8, or 16 mumol of iron per kilogram of body weight). Three blinded readers evaluated the precontrast and 10- and 40-minute postcontrast MR images of 54, 58, and 57 patients, respectively.


RESULTS
Statistically significant differences were observed in diagnostic confidence between images obtained with a dose of 4 or 16 mumol Fe/kg (P = .011) and in good or excellent improvement, respectively, in delineation of lesions on 10-minute postcontrast images (P = .001). No apparent differences in the efficacy evaluation were seen between the 10- and 40-minute postcontrast imaging time points.


CONCLUSIONS
There was a dose-dependent postcontrast improvement in evaluated efficacy parameters (diagnostic confidence, visual evaluations) after injection of SH U 555 A. Accumulation phase imaging could begin as early as 10 minutes after administration.
Shamsi
K
K
Department of Magnetic Resonance and Ultrasound Contrast Media, Schering, Berlin, Germany.
Balzer
T
T
Saini
S
S
Ros
P R
PR
Nelson
R C
RC
Carter
E C
EC
Tollerfield
S
S
Niendorf
H P
HP
D003287:Contrast Media / Q000008:administration & dosage*; D003911:Dextrans; D004305:Dose-Response Relationship, Drug; D005069:Evaluation Studies as Topic; D005260:Female; D052203:Ferrosoferric Oxide; D006801:Humans; D007275:Injections, Intravenous; D007501:Iron / Q000008:administration & dosage*; D008099:Liver / Q000473:pathology*; D008107:Liver Diseases / Q000175:diagnosis; D008113:Liver Neoplasms / Q000175:diagnosis*; D008279:Magnetic Resonance Imaging / Q000379:methods*; D058185:Magnetite Nanoparticles; D008297:Male; D008875:Middle Aged; D010087:Oxides / Q000008:administration & dosage*; D013535:Suspensions; D013997:Time Factors
D003287:Contrast Media; D003911:Dextrans; D058185:Magnetite Nanoparticles; D010087:Oxides; D013535:Suspensions; D007501:Iron; C065507:ferumoxides; D052203:Ferrosoferric Oxide